The purpose of this Notice is to modify the language of RFA-HL-11-018. Given prevalence of severe asthma (5-10% of subjects with asthma), an accrual target of 2250 patients for six clinical centers in the first three award years for six clinical centers is not realistic and may adversely influence potential applicant pool. NHLBI has reduced the requirements in RFA-HL-11-018 (Clinical Centers for the Severe Asthma Research Program) for patient recruitment to an accrual target of 1440 patients for the six clinical centers in the first three years.

Thus the relevant text in RFA-HL-11-018 is now changed to the following:

Section I. Funding Opportunity Description;

1. Research Objectives

Program Structure

Clinical Centers (CC):

Clinical Center applicants are required to (1) demonstrate current access to at least 50 subjects with severe asthma as defined by the American Thoracic Society (Am J Respir Crit Care Med 2000:162;2341-2351) and (2) demonstrate ability to recruit at least 80 subjects per year - for the first three award years - with persistent asthma as defined by the NAEPP EPR-3 Guidelines for the Diagnosis and Management of Asthma (see http://www.nhlbi.nih.gov/guidelines/asthma/) (60% severe of which 25% are children including preadolescents).

Section IV. Application and Submission Information;

6. Other Submission Requirements

3. Research Strategy

For planning purposes, each applicant will assume a participant pool and accrual pattern consistent with this FOA. That is, applicants are required to demonstrate
(1) current access to at least 50 subjects with severe asthma as defined by the American Thoracic Society (Am J Respir Crit Care Med 2000:162;2341-2351) and
(2) ability to recruit at least 80 subjects per year - for the first three award years - with persistent asthma as defined by the NAEPP EPR-3 Guidelines for the Diagnosis and Management of Asthma (see http://www.nhlbi.nih.gov/guidelines/asthma/ (60% severe of which 25% are children including preadolescents). Total accrual projected for applicant’s center should be presented using the PHS 398 Targeted/Planned Enrollment Table. All participants enrolled in SARP will undergo baseline characterization and shared longitudinal protocol.

Budget Plan for Shared Longitudinal Protocol.
The budget should indicate the total direct costs of conducting the proposed shared longitudinal protocol (e.g., including baseline characterization and 36- to 48-month follow-up data collection in approximately 1440 participants over six-years) across all Clinical Centers (assuming six CCs). Accrual should begin within six-months of award.

Section V. Application Review Information

Scored Review Criteria

Approach
Does the proposed research reflect a need for the SARP structure? Is there evidence demonstrating current access to (1) at least 50 subjects with severe asthma as defined by the American Thoracic Society and (2) demonstrated ability to recruit at least 80 subjects per year - for the first three award years - with persistent asthma as defined by the NAEPP EPR-3 Guidelines (60% severe of which 25% are children including preadolescents)?

All other aspects of the FOA remain unchanged. NHLBI apologizes for any confusion generated by these errors.

Inquiries

We encourage your inquiries concerning RFA-HL-11-018 or this Notice and welcome the opportunity to answer questions from potential applicants: